- 3Q22 net sales of $130.7 million
- Prescription Drug User Fee Act action date
set for March 12, 2023 for trofinetide for the treatment of Rett
syndrome
Acadia Pharmaceuticals Inc. (Nasdaq: ACAD), today announced its
financial results for the third quarter ended September 30,
2022.
NUPLAZID delivered net sales of $130.7 million in the third
quarter of 2022, driven by sequential demand growth of 2% and an
acceleration of growth in the long-term care (LTC) channel, offset
by a reduction of in-channel inventory of approximately $7
million.
“Our third quarter results reflect continued growth in demand
for NUPLAZID, driven by early signs of improvement in the long-term
care channel,” said Steve Davis, Chief Executive Officer. “In the
quarter we announced that our new drug application of trofinetide
for the treatment of Rett syndrome has been accepted for filing by
the FDA and granted a priority review. Furthermore, we continued to
advance our late and early-stage portfolio, including our Phase 3
program for pimavanserin for the treatment of the negative symptoms
of schizophrenia and our Phase 1 ACP-204 program for
neuropsychiatric indications.”
Company Updates
- Trofinetide New Drug Application (NDA) for the treatment of
Rett syndrome was accepted for filing by the U.S. Food and Drug
Administration (FDA). The FDA granted a priority review and
assigned a PDUFA (Prescription Drug User Fee Act) action date of
March 12, 2023, and informed the company that they are not planning
to hold an Advisory Committee meeting.
- Presented clinical data for trofinetide at medical congresses
in October, including the positive Phase 3 Lavender results and the
Daffodil study in girls aged 2-4 with Rett syndrome, at the 51st
Annual Meeting of the Child Neurology Society (CNS) in Cincinnati,
OH and the National Organization for Rare Diseases (NORD) &
Orphan Products 2022 Summit in Washington, DC.
- Continue to expect enrollment to complete in ADVANCE-2, a Phase
3 study evaluating pimavanserin for the negative symptoms of
schizophrenia, around mid-year 2023.
- Announced that Acadia’s President Serge Stankovic, M.D.,
M.S.P.H. will retire at the end of the year. A search for a
successor to Dr. Stankovic is ongoing. Following his retirement,
Dr. Stankovic will provide consulting and advisory services for
Acadia on a part-time basis.
- Appointed Adora Ndu, Pharm.D., J.D. to Acadia’s Board of
Directors. Dr. Ndu is a biopharma executive with significant
regulatory and clinical development experience, combined with an
extensive background in rare disease that nicely complements the
skill sets of Acadia’s current Board membership.
Financial Results
Revenue
Net sales of NUPLAZID® (pimavanserin) were $130.7 million for
the three months ended September 30, 2022, a decrease of 1% as
compared to $131.6 million reported for the three months ended
September 30, 2021. Net sales for the quarter were driven by
sequential demand growth of 2% and an acceleration of growth in the
LTC channel, offset by a reduction of in-channel inventory of
approximately $7 million. For the nine months ended September 30,
2022, Acadia reported net product sales of $380.7 million, an
increase of approximately 8% as compared to $353.4 million reported
for the nine months ended September 30, 2021.
Research and Development
Research and development expenses for the three months ended
September 30, 2022 were $81.3 million, compared to $58.6 million
for the same period of 2021. The increase in research and
development expenses during the quarter was primarily due to a $10
million milestone payment accrued to Neuren upon acceptance of the
trofinetide NDA filing, as well as increased costs of manufacturing
activities for trofinetide and the development of early-stage
programs. For the nine months ended September 30, 2022 and 2021,
research and development expenses were $285.8 million and $172.5
million. The increase was primarily due to the $60 million upfront
payment made to Stoke Therapeutics for a license and collaboration
agreement and the previously mentioned $10 million milestone as
well as increased costs for trofinetide and early-stage
programs.
Selling, General and Administrative
Selling, general and administrative expenses for the three
months ended September 30, 2022 were $78.1 million, compared to
$81.7 million for the same period of 2021. For the nine months
ended September 30, 2022 and 2021, selling, general and
administrative expenses were $264.7 million and $290.1 million,
respectively. The decrease was primarily due to decreased
advertising and promotional costs.
Net Loss
For the three months ended September 30, 2022, Acadia reported a
net loss of $27.2 million, or $0.17 per common share, compared to a
net loss of $14.5 million, or $0.09 per common share, for the same
period in 2021. The net losses for the three months ended September
30, 2022 and 2021 included $18.3 million and $15.5 million,
respectively, of non-cash stock-based compensation expense. For the
nine months ended September 30, 2022, Acadia reported a net loss of
$174.3 million, or $1.08 per common share, compared to a net loss
of $124.8 million, or $0.78 per common share, for the same period
in 2021. The increase was mainly due to the upfront and milestone
payments made for license and collaboration agreements in 2022. The
net losses for the nine months ended September 30, 2022 and 2021
included $53.8 million and $50.7 million, respectively, of non-cash
stock-based compensation expense.
Cash and Investments
At September 30, 2022, Acadia’s cash, cash equivalents, and
investment securities totaled $436.6 million, compared to $520.7
million at December 31, 2021.
2022 Financial Guidance
- NUPLAZID net sales guidance is updated to $510 to $520 million
from the previous range of $510 to $540 million.
- GAAP R&D guidance is updated to $345 to $355 million from
the previous range of $340 to $360 million, which includes
approximately $25 million of stock-based compensation expense.
- GAAP SG&A guidance is updated to $365 to $375 million from
the previous range of $360 to $380 million, which includes
approximately $45 million of stock-based compensation expense.
Conference Call and Webcast Information
The conference call may be accessed by registering for the call
here. Once registered, participants will receive an email with the
dial-in number and unique PIN number to use for accessing the call.
The registration link will also be available on Acadia’s website,
www.acadia.com under the investors section and will be archived
there until December 7, 2022.
About NUPLAZID® (pimavanserin)
Pimavanserin is a selective serotonin inverse agonist and
antagonist preferentially targeting 5-HT2A receptors. These
receptors are thought to play an important role in neuropsychiatric
disorders. In vitro, pimavanserin demonstrated no appreciable
binding affinity for dopamine (including D2), histamine,
muscarinic, or adrenergic receptors. Pimavanserin was approved for
the treatment of hallucinations and delusions associated with
Parkinson’s disease psychosis by the U.S. Food and Drug
Administration in April 2016 under the trade name NUPLAZID. In
addition, Acadia is developing pimavanserin in other
neuropsychiatric conditions.
About Trofinetide
Trofinetide is an investigational drug. It is a novel synthetic
analog of the amino‐terminal tripeptide of IGF-1 designed to treat
the core symptoms of Rett syndrome by potentially reducing
neuroinflammation and supporting synaptic function. Trofinetide is
thought to stimulate synaptic maturation and overcome the synaptic
and neuronal immaturities that are characteristic of Rett syndrome
pathophysiology. In the central nervous system, IGF-1 is produced
by both of the major types of brain cells – neurons and glia. IGF-1
in the brain is critical for both normal development and for
response to injury and disease. Trofinetide has been shown to
inhibit the production of inflammatory cytokines, inhibit the
overactivation of microglia and astrocytes, and increase the amount
of available IGF-1 that can bind to IGF-1 receptors.
About Acadia Pharmaceuticals
Acadia is advancing breakthroughs in neuroscience to elevate
life. For more than 25 years we have been working at the forefront
of healthcare to bring vital solutions to people who need them
most. We developed and commercialized the first and only approved
therapy for hallucinations and delusions associated with
Parkinson’s disease psychosis. Our clinical-stage development
efforts are focused on treating the negative symptoms of
schizophrenia, Rett syndrome and neuropsychiatric symptoms in
central nervous system disorders. For more information, visit us at
www.acadia.com and follow us on LinkedIn and Twitter.
Forward-Looking Statements
Statements in this press release that are not strictly
historical in nature are forward-looking statements. These
statements include, but are not limited to, statements related to:
the potential opportunity for future growth in sales of NUPLAZID;
the timing of ongoing and future clinical studies for pimavanserin;
the development and commercialization of trofinetide; and guidance
for full-year 2022 NUPLAZID net sales for Parkinson’s disease
psychosis only and certain expense line items. These statements are
only predictions based on current information and expectations and
involve a number of risks and uncertainties. Actual events or
results may differ materially from those projected in any of such
statements due to various factors, including the uncertainty of
future commercial sales and related items that would impact net
sales during 2022, the risks and uncertainties inherent in drug
development, approval and commercialization, and the fact that past
results of clinical trials may not be indicative of future trial
results. For a discussion of these and other factors, please refer
to Acadia’s annual report on Form 10-K for the year ended December
31, 2021 as well as Acadia’s subsequent filings with the Securities
and Exchange Commission. You are cautioned not to place undue
reliance on these forward-looking statements, which speak only as
of the date hereof. This caution is made under the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995.
All forward-looking statements are qualified in their entirety by
this cautionary statement and Acadia undertakes no obligation to
revise or update this press release to reflect events or
circumstances after the date hereof, except as required by law.
ACADIA PHARMACEUTICALS
INC.
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS
(in thousands, except per share
amounts)
(Unaudited)
Three Months Ended September
30,
Nine Months Ended September
30,
2022
2021
2022
2021
Revenues
Product sales, net
$
130,714
$
131,612
$
380,745
$
353,387
Total revenues
130,714
131,612
380,745
353,387
Operating expenses
Cost of product sales, license fees and
royalties (1)
2,136
6,682
7,753
16,580
Research and development (1)
81,336
58,565
285,837
172,473
Selling, general and administrative
(1)
78,108
81,666
264,688
290,116
Total operating expenses
161,580
146,913
558,278
479,169
Loss from operations
(30,866
)
(15,301
)
(177,533
)
(125,782
)
Interest income, net
2,295
129
2,980
462
Other income
2,156
383
1,999
706
Loss before income taxes
(26,415
)
(14,789
)
(172,554
)
(124,614
)
Income tax expense (benefit)
768
(332
)
1,696
162
Net loss
$
(27,183
)
$
(14,457
)
$
(174,250
)
$
(124,776
)
Net loss per common share, basic and
diluted
$
(0.17
)
$
(0.09
)
$
(1.08
)
$
(0.78
)
Weighted average common shares
outstanding, basic and diluted
161,852
160,663
161,580
159,651
(1) Includes the following stock-based
compensation expense
Cost of product sales, license fees and
royalties
$
344
$
439
$
1,013
$
1,025
Research and development
$
6,452
$
5,176
$
19,148
$
17,325
Selling, general and administrative
$
11,516
$
9,931
$
33,626
$
32,385
ACADIA PHARMACEUTICALS
INC.
CONDENSED CONSOLIDATED BALANCE
SHEETS
(in thousands)
September 30, 2022
December 31, 2021
(unaudited)
Assets
Cash, cash equivalents and investment
securities
$
436,579
$
520,706
Accounts receivable, net
55,733
64,366
Interest and other receivables
403
978
Inventory
5,844
7,881
Prepaid expenses
22,993
23,892
Total current assets
521,552
617,823
Property and equipment, net
6,510
8,047
Operating lease right-of-use assets
56,624
58,268
Restricted cash
5,770
5,770
Long-term inventory
5,992
6,217
Other assets
6,043
3,997
Total assets
$
602,491
$
700,122
Liabilities and stockholders’
equity
Accounts payable
$
10,008
$
6,876
Accrued liabilities
106,562
89,192
Total current liabilities
116,570
96,068
Operating lease liabilities
53,769
56,126
Other long-term liabilities
6,466
7,034
Total liabilities
176,805
159,228
Total stockholders’ equity
425,686
540,894
Total liabilities and stockholders’
equity
$
602,491
$
700,122
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221102005797/en/
Media Contact: Acadia Pharmaceuticals Inc. Deb Kazenelson (818)
395-3043 media@acadia-pharm.com
Investor Contact: Acadia Pharmaceuticals Inc. Mark Johnson, CFA
(858) 261-2771 ir@acadia-pharm.com
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